FDA Approves New Treatment For ADHD In Pediatric Patients
April 2, 2021   

The U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

Viloxazine (Figure) is considered a “multimodal agent” in that it both blocks the norepinephrine (NE) reuptake pump and directly modulates several serotonin (5-HT) receptors with elevation of intrasynaptic serotonin levels. Clinical data of the mechanism of action shows that in vitro, viloxazine demonstrated antagonistic activity at 5-HT2B and agonistic activity at 5-HT2C receptors, along with high receptor occupancy at clinical doses. In vivo, viloxazine increased extracellular NE, 5-HT, and dopamine (DA) levels in the prefrontal cortex and it produced a minimal increase in DA levels in the nucleus accumbens. Viloxazine exhibited moderate inhibitory effects on the norepinephrine transporter in vitro and in vivo and no inhibitory effect on the serotonin transporter.

The approval of viloxazine is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.

>> Supernus Pharmaceuticals Press Release


Yu C et al. J Exp Pharmacol. 2020 Aug 25;12:285-300. Abstract

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